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Friday, April 12, 2024 8:52:09 PM
they first would have seen control patients that were eventing later than the treatment arm because the treatment arm was showing false progression - pseudo progression / psPD - due to DCVax-l that couldn't be measured correctly due to the antiquated progression determination criteria). But at the same time, they would have also (likely) seen that progression in the treatment patients was also disappearing with time. The FDA may have also seen from the data that some of the control arm patients that were crossing over were also demonstrating psPD after crossing over, that later went away.
Could this have also contributed to the evolution of RANO to iRANO as it seems to have happened in that time frame?
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